Prostate Adenocarcinoma
Conditions
Brief summary
A Phase II Randomized Trial of Hypofractionated Proton Therapy in Patients With A Localized Prostate Adenocarcinoma
Detailed description
For Proton therapy with prostate adenocarcinoma patients. Arm 1: Proton therapy 3CGE x 20days = Total 60 CGE for 4 weeks. Arm 2: Proton therapy 4.7CGE x 10days = Total 47 CGE for 2 weeks.
Interventions
DEVICEProton Therapy
Sponsors
National Cancer Center, Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* Biopsy proven prostate adenocarcinoma Stage: T1-T2cN0M0 * ECOG performance status:0-1 * Signed study specific informed consent prior to study entry.
Exclusion criteria
* Postoperative residual or recurrent tumor * Evidence of distant metastasis previous irradiation for the tumor in the same location * Adjuvant anti-androgenic hormonal therapy High risk group (NCCN guide line)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BCFFS | up to 5 years from a initial follow-up | To evaluate biochemical failure-free survival (BCFFS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute/late toxicity (CTCAE v4.0) | up to 5 years from a initial follow-up | Common Terminology Criteria for Adverse Events (CTCAE) V 4.0 |
| Disease specific survival | up to 5 years from a initial follow-up | follow-up |
| EPIC (Extended Prostate Cancer Index Composite) | up to 5 years from a initial follow-up | questionnaire |
Countries
South Korea
Contacts
Primary ContactKwanho Cho
Outcome results
None listed